Trials / Unknown
UnknownNCT02523352
Effects of PEEP on Heart and Lungs in Obese Subjects
Evaluation of Effects of Positive End-expiratory Pressure (PEEP) on Lung and Heart Functions in Spontaneous Breathing Obese Subjects.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Aim of this study is to better understand pathophysiology of the alteration of respiratory mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to test this hypothesis with a physiological, interventional study conducted on volunteers by using Electrical Impedance Tomography in a group of patients and magnetic resonance imaging (MRI) in another group.
Detailed description
Obese subjects are prone to develop respiratory insufficiency when requiring mechanical ventilation. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. The investigators do believe that the respiratory system derangements observed in the previous study during the critical illness are already present, although in lower severity, in the obese patients in their basal condition. This study will help to understand the standard cardiac and respiratory function of an obese non critically ill subject to better target the therapies during the management of the critical illness to reestablish the homeostasis of the system: The investigator's hypotheses are: * To demonstrate if morbidly obese patients show atelectasis at spontaneous breathing in the supine position and whether the increase in lung volume following PEEP titration is due to alveolar recruitment rather than overdistention. * To measure regional variations in ventilation/perfusion coupling at different ventilator settings * To investigate the role of diaphragm position in the development/treatment of respiratory insufficiency due to increased pleural pressure * To test if reopening of lung atelectasis through the application o a recruitment maneuver and titrated PEEP level would lead to an improvement in right heart function. * To assess pulmonary circulation at different levels of PEEP.
Conditions
- Obesity
- Pulmonary Atelectasis
- Obesity Hypoventilation Syndrome
- Magnetic Resonance Imaging
- Respiratory Mechanics
- Electrical Impedance Tomography
- Trans-Thoracic Echocardiography
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Non-Invasive Ventilation | Progressive increase in airway pressure to open lungs atelectatic regions. |
| PROCEDURE | Esophageal catheter positioning | The esophageal tube (8 French diameter catheter) will be positioned in the larger nostril previous topical anesthesia |
Timeline
- Start date
- 2018-04-05
- Primary completion
- 2021-12-31
- Completion
- 2022-12-31
- First posted
- 2015-08-14
- Last updated
- 2020-11-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02523352. Inclusion in this directory is not an endorsement.